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Biotech / Medical : ProMetic Life Sciences

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From: axial	10/19/2017 3:38:53 PM
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Another brick in the wall — PROMETIC RECEIVES PRIORITY REVIEW STATUS FROM HEALTH CANADA FOR PLASMINOGEN (RYPLAZIM™) 'Prometic plans to file its NDS with Health Canada in the fourth quarter of 2017Laval, Quebec, Canada – October 19, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that Health Canada has granted priority review status for the New Drug Submission (NDS) the company plans to file for its plasminogen replacement therapy (RyplazimTM) for the treatment of patients with plasminogen deficiency. Priority review status is granted by Health Canada to a NDS for serious, life-threatening or severely debilitating diseases or conditions for which there is substantial evidence of clinical effectiveness that the drug provides: An effective treatment, prevention or diagnosis of a disease or condition for which no drug is currently marketed in Canada; or A significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada. “We are pleased to have secured another priority review status for RyplazimTM”, said Pierre Laurin, President and Chief Executive Officer of Prometic. “We see this as further validation by a regulatory authority of the potential value of this life-changing drug in the treatment of plasminogen deficiency. We look forward to continuing to work with Health Canada to bring this innovative therapy to patients suffering from plasminogen deficiency”. Priority Review status assigns eligible submissions a shortened review target of 180 days, in comparison to 300 days for non-priority. Health Canada believes it is in the best interests of Canadians to review potentially life-saving drugs as early as possible.' Jim

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